SRI International, an over 75-year strong pioneering research institute, has a rich history supporting government and industry. Our innovations have created new industries, billions of dollars in market value and lasting benefits to society. SRI is organized around broad disciplines and capabilities, with research and development divisions and labs to groups who excel at identifying new opportunities, developing products and creating custom solutions. Our organization is driven by impact – delivering unique solutions for the world’s important challenges and transforming ideas into reality for clients and partners.

This is an opportunity to be exposed to a wide array of types of study design, a wide array of type of therapeutics.  You will be handling the design, planning, and have responsibility for the overall scientific condusct of a study.  We are looking for someone who as a study director has designed and carried out GLP studies in toxicology.  The ideal candidate has a background in histopathology, clinical pathology and the related data analysis of both.

The Toxicology group in the Biosciences Division at SRI International in Menlo Park California is seeking a highly motivated, detail orientated, well organized, and skilled Toxicologist.

This opportunity is well suited for a motivated and energetic PhD scientist who shares our group’s passion for innovation, quality work, and producing results.

• The Toxicologist must have the ability to lead and enjoy overcoming challenges while creating and maintaining positive team relationships.
• This position will direct the design and management of pre-clinical regulated in vivo studies, as well as other studies that support IND applications to FDA.
• The Toxicologist must be able to work in a fast-paced, deadline-oriented environment, while maintaining a positive attitude.
• The Toxicologist needs awareness of research methodology and concepts, regulations, planning, and strategies.
• The Toxicologist demonstrates growth potential to expand role to take on management of large product development programs.

Responsibilities:

• Assist in the development of appropriate safety testing programs for candidate biomedical products (drugs, vaccines and/or devices)
• Serve as a Study Director to plan, design, and effectively lead a team to conduct complex toxicity studies in compliance with FDA GLP and ICH regulations and generate high quality scientific results for SRI’s clients (commercial or government)
• Has overall responsibility for the technical conduct of a study as well as interpretation, analysis, documentation, and reporting of the results
• Multi-task, manage customer projects, and customer interactions
• Address and resolve toxicological issues arising during the conduct of the studies
• Communicate critical and significant project information to project teams
• Coordinate toxicological/nonclinical safety studies with other contract laboratories for certain Specialized studies
• Initiate and mange commercial and/or government contracts for preclinical drug development
• Maintain and advance technical, professional, leadership and communication skills through continuing education courses
• Attend and participate in scientific conferences and meetings
• Publish critical findings of appropriate work in peer-reviewed journals

• Ph.D. in Toxicology or relevant field with 3-8 years of experience in the conduct of safety studies in rodents or other species.
• Experience must be as Study Director
• Experience with in vivo study design and execution and clinical/histopath data analysis
• DABT Board Certification or willingness / readiness to obtain Board Certification
• Broad knowledge in general concepts of toxicology
• Knowledge of US and international regulatory guidelines related to drug development
• Demonstrated ability to manage multiple scientific projects and make sound scientific interpretations
• Demonstrated experience leading teams and driving results
• Willing and able to work under the pressure of deadlines and find solutions to meet timelines
• Strong problem solving and organizational skills with the ability to thrive and lead in an environment where multitasking is required
• Strong interpersonal skills with an ability to develop solid, long-term relationships and to work effectively in a team setting organization
• Willing and able to work within a Quality System with oversight by QA and other regulatory bodies.
• Excellent oral and written communication skills